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FDA 510(k), K123632, 2.5MM TURBO ELITE 035, 2.3MM TURBO ELITE 035
FDA 510(k), K123632, 2.5MM TURBO ELITE 035, 2.3MM TURBO ELITE 035
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510(K) Number: K123632
Device Name: 2.5MM TURBO ELITE 035, 2.3MM TURBO ELITE 035
Manufacturer: SPECTRANETICS CORP.
Device Classification Name: catheter, peripheral, atherectomy
Regulation Number: 870.4875
Classification Product Code: MCW
Date Received: 11/23/2012
Decision Date: 01/25/2013
Regulation Medical Specialty: Cardiovascular
Device Name: 2.5MM TURBO ELITE 035, 2.3MM TURBO ELITE 035
Manufacturer: SPECTRANETICS CORP.
Device Classification Name: catheter, peripheral, atherectomy
Regulation Number: 870.4875
Classification Product Code: MCW
Date Received: 11/23/2012
Decision Date: 01/25/2013
Regulation Medical Specialty: Cardiovascular
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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